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Terminated

Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.

FDA Recall Z-2243-2010 · Posted 2010-08-20

Recalling FirmBioCheck Inc
Recall StatusTerminated
Product CodeNUK
Date Initiated2010-07-15
Date Terminated2010-12-13
Product Quantity187 kits

Reason for Recall

Products were marketed without 510(k) for diagnostic use. Unapproved device.

Firm Action

BioCheck sent an "Urgent Device Recall" letter dated July 15, 2010 to consignees identifying the products as unapproved and requesting prompt return to the firm. Consignees are asked to sub-recall. The letter requested a reponse form be completed and returned to the firm. Diagnostic claims have been removed from the website. Returned product will be quarantined by the firm pending determination of marketing status and labeling revision.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution - USA, including the states of CA, MI, NJ, and PA and countries of Canada, India, S. Korea, and UAE.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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